Mersana Therapeutics Announces Upcoming Oral Presentation of Emi-Le Clinical Data at European Society for Medical Oncology (ESMO) Breast Cancer 2025 Annual Congress

On April 2, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that Phase 1 dose escalation and backfill cohort clinical data for emiltatug ledadotin (Emi-Le; XMT-1660) will be presented in an oral session at the ESMO (Free ESMO Whitepaper) Breast Cancer 2025 Annual Congress, which is being held from May 14-17, 2025, in Munich, Germany (Press release, Mersana Therapeutics, APR 1, 2025, View Source [SID1234651761]).

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Oral Presentation Details

Title: Clinical Activity of Emiltatug Ledadotin (Emi-Le), a B7-H4-Directed ADC, in Patients with TNBC who Received at Least One Prior Topoisomerase-1 Inhibitor (Topo-1) ADC

Session Title: Mini Oral Session 1

Date and Time: Thursday, May 15, 2025 from 8:30-10:00 a.m. CEST

Abstract Number: 298MO

Presenter: Erika Hamilton, M.D., Director Breast Cancer Research, Sarah Cannon Research Institute in Nashville, Tennessee

About Emi-Le
Emi-Le is a B7-H4-directed Dolasynthen ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6) and a proprietary auristatin payload with controlled bystander effect. This candidate is being investigated in a Phase 1 dose escalation and expansion trial in patients with solid tumors, including breast, endometrial and ovarian cancers as well as adenoid cystic carcinoma type 1. In the initial clinical data that were reported as of a December 13, 2024 data cutoff, Emi-Le was observed to be generally well tolerated with differentiated safety and tolerability profile. Additionally, confirmed objective responses were observed across all enrolled tumor types, including in patients with triple negative breast cancer (TNBC) who had previously been treated with a topoisomerase-1 inhibitor (topo-1) ADC.

The U.S. Food and Drug Administration has granted two Fast Track designations to Emi-Le for the treatment of 1) adult patients with advanced or metastatic triple-negative breast cancer, and 2) advanced or metastatic breast cancer in patients with human epidermal growth factor receptor 2 (HER2) low (IHC 1+ or IHC 2+/ISH–) or HER2-negative (IHC 0) disease, including TNBC, who have received a prior topo-1 ADC. For more information about Mersana’s ongoing Phase 1 trial of Emi-Le, please visit clinicaltrials.gov (NCT05377996).

Entry into a Material Definitive Agreement

On April 1, 2025 Citius Pharmaceuticals, Inc. (the "Company") entered into a securities purchase agreement (the "Purchase Agreement") with a certain institutional investor for the issuance and sale, in a registered direct offering by the Company (the "Offering"), of 465,000 shares of the Company’s common stock, par value $0.001 per share (the "Shares"), and pre-funded warrants to purchase up to 1,274,131 shares of common stock (the "Pre-funded Warrants") at an offering price of $1.15 and $1.1499, respectively (Filing, 8-K, Citius Pharmaceuticals, APR 1, 2025, View Source [SID1234651752]). The Offering closed on April 2, 2025.

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The Pre-funded Warrants are exercisable immediately at an exercise price of $0.0001 per share and shall remain valid and exercisable until all the Pre-funded Warrants are exercised in full. A holder of a Pre-funded Warrant will not have the right to exercise any portion of its warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or 9.99% at the election of the holder prior to the date of issuance) of the number of shares of common stock outstanding immediately after giving effect to such exercise (the "Beneficial Ownership Limitation"); provided, however, that upon 61 days’ prior notice to the Company, the holder may increase or decrease the Beneficial Ownership Limitation, provided that in no event shall the Beneficial Ownership Limitation exceed 9.99%. The exercise price and number of shares of common stock issuable upon exercise are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the common stock and the exercise price.

H.C. Wainwright and Co., LLC ("Wainwright") acted as the Company’s exclusive placement agent in connection with the Offering. In connection with the Offering, the Company agreed to pay Wainwright a cash fee of 7.0% of the gross proceeds the Company received in the Offering. The Company agreed to also reimburse Wainwright up to $25,000 for fees and expenses of legal counsel, $10,000 for non-accountable expenses and $10,000 for a clearing fee. In addition, the Company granted placement agent warrants to Wainwright, or its designees, to purchase up to 121,739 shares of the common stock (the "Placement Agent Warrants").

The Placement Agent Warrants have an exercise price equal to $1.4375 per share, are exercisable six months after issuance and will expire five years from the commencement of sales in the Offering. The exercise price and number of shares of common stock issuable upon exercise are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the common stock and the exercise price. If there is no effective registration statement for the resale of the shares issuable upon exercise of the Placement Agent Warrants, holders of the Placement Agent Warrants may elect a "cashless" exercise, whereby they would receive the net number of shares of common stock determined according to a formula set forth in the Placement Agent Warrants. On the expiration date of the Placement Agent Warrants, any Placement Agent Warrants outstanding and unexercised will be automatically exercised via cashless exercise.

The net proceeds to the Company from the Offering were approximately $1.735 million, after deducting placement agent fees and other offering expenses payable by the Company. The Company anticipates using the net proceeds to support the commercial launch of LYMPHIR and general corporate purposes.

Pursuant to the Purchase Agreement, the Company agreed for a period of 30 days following the closing of the Offering not to issue, enter into an agreement to issue or announce the issuance or proposed issuance of the shares or any other securities convertible into, or exercisable or exchangeable for, shares of common stock, subject to certain exceptions.

The Offering was made pursuant to the Company’s effective registration statement on Form S-3 (File No. 333-277319), which was previously declared effective by the Securities and Exchange Commission (the "SEC") on March 1, 2024, including a prospectus supplement filed with the SEC on April 1, 2025.

The Purchase Agreement contains customary representations and warranties and agreements of the Company and the investors and customary indemnification rights and obligations of the parties. The representations, warranties and covenants contained in the Purchase Agreement were made solely for the benefit of the parties to the Purchase Agreement and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Purchase Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Purchase Agreement, and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the SEC.

The foregoing descriptions of the Purchase Agreement, the Pre-funded Warrants and the Placement Agent Warrants are qualified in their entirety by reference to the forms of the Purchase Agreement, the Pre-funded Warrants and the Placement Agent Warrants, copies of which are attached hereto as Exhibits 10.1, 4.1 and 4.2, respectively, and are incorporated herein by reference. A copy of the opinion of Wyrick Robbins Yates & Ponton LLP relating to the legality of the issuance and sale of the Shares, the Pre-funded Warrants and the Placement Agent Warrants in the Offering is attached as Exhibit 5.1 hereto.

enGene to Present at the Stifel 2025 Virtual Targeted Oncology Forum

On April 1, 2025 enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported that Ron Cooper, Chief Executive Officer, will present at the Stifel 2025 Virtual Targeted Oncology Forum, on Tuesday, April 8, 2025, at 4:00 p.m. ET (Press release, enGene, APR 1, 2025, View Source [SID1234651738]).

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A live webcast of the presentation can be accessed under the "Investors" section of the enGene website at www.engene.com and will be archived there for 90 days.

BBOT Announces First Patient Dosed with BBO-11818, a PanKRAS Dual Inhibitor, in the Phase 1 KONQUER-101 Trial for Advanced Solid Tumors

On April 1, 2025 TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics ("BBOT" or the "Company"), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported that the first patient has been dosed with BBO-11818 in the Phase 1 KONQUER-101 trial for advanced solid tumors (Press release, BridgeBio Oncology Therapeutics, APR 1, 2025, View Source [SID1234651737]). BBO-11818 is an orally bioavailable small molecule dual inhibitor that directly binds to both the "ON" and "OFF" states of KRAS. KONQUER-101 will enroll patients globally with certain KRAS mutations.

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"The dosing of the first patient is a major milestone in assessing BBO-11818’s potential benefit for patients with tumors driven by mutant KRAS," said Dr. Ignacio Garrido-Laguna, MD, PhD, Principal Investigator at Huntsman Cancer Institute at the University of Utah. "We are committed to bringing cutting-edge therapies to patients with advanced cancer in the Mountain Region. BBO-11818 has the potential to safely achieve optimal target inhibition and combine with other targeted therapies. We look forward to evaluating it in the KONQUER-101 trial."

BBO-11818 was designed to non-covalently bind both the inactive GDP-bound "OFF" and active GTP-bound "ON" forms of KRASG12D and KRASG12V. In cellular assays, EC50 values for pERK inhibition in selected KRAS G12D and G12V-mutant cell lines range from sub-nanomolar to single-digit nanomolar potency. BBO-11818 is similarly effective in reducing cell viability in KRASG12D, KRASG12V, and KRASG12C-mutant cell lines. Further, NRAS and BRAF mutant cell lines show insensitivity to BBO-11818, and the molecule exhibits more than 500-fold selectivity for KRAS over H- and NRAS.

"There is a great need for new therapies that can safely treat patients with tumors driven by KRAS mutations, as the current standard of care lacks satisfactory options as monotherapy or to enable combinations of KRAS targeted therapies with other targeted agents," said Yong (Ben) Ben, MD, Chief Medical and Development Officer of BBOT. "BBO-11818 marks the third molecule entering the clinic for BBOT, further proving our capability to advance novel programs into the clinic. Of note, our portfolio is uniquely positioned to deliver the combination of MAPK (BBO-8520 and BBO-11818) and PI3Kα/AKT (BBO-10203) co-inhibition, with a therapeutic index. We hope this will bring unprecedented benefit to patients with RAS-driven cancers."

The discovery of BBO-11818 was the result of a collaboration between the RAS Initiative at Frederick National Laboratory, Lawrence Livermore National Laboratory, and BBOT.

Amneal Launches BORUZU™, First Ready-to-Use Bortezomib Injection for Multiple Myeloma and Mantle Cell Lymphoma

On April 1, 2025 Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company"), a global biopharmaceutical company, and Shilpa Medicare Limited ("Shilpa") reported the U.S. launch of BORUZU, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration (Press release, Amneal Pharmaceuticals, APR 1, 2025, View Source [SID1234651736]). This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration.

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BORUZU (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This product references the branded product Velcade, a lyophilized powder requiring reconstitution before use. Shilpa developed the molecule and Amneal will manufacture and commercialize the product. BORUZU has a unique J-code.

"As we advance our broader strategy to build a leading injectables portfolio with durable, high-impact complex products, we are excited to announce the U.S. launch of BORUZU in our oncology portfolio. This ready-to-use injectable marks a significant innovation for our customers by streamlining pharmacy preparation steps for clinicians while now carrying a unique J-code to facilitate reimbursement. Our commitment remains steadfast in delivering differentiated oncology products that enhance patient care and access," said Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology.

"This second NDA product being launched in the US market from our novel injectable portfolio demonstrates our capabilities and commitment to introduce pharmacy efficient solutions that enhance compliance and have the potential to reduce patient wait times. This development exemplifies Shilpa’s constant endeavor to work towards introducing novel first of its kind pharmaceutical products that help improve the healthcare requirements of a large patient pool," said Vishnukant Bhutada, Managing Director of Shilpa Medicare.

The most commonly reported adverse reactions for BORUZU in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia.